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The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic guidance features: freehand navigation and robotic guidance.
The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.
The robotic guidance feature utilizes the same principle of optical position determination technology. The system componentss include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the SURGIVISIO Device:

Note: The provided text is an FDA 510(k) summary, which often focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing the design and execution of individual performance studies, especially clinical ones. As such, some of the requested information (like specific sample sizes for test/training sets, detailed expert qualifications, adjudication methods, and MRMC study details) is not explicitly present or fully elaborated in this type of document. I will extract what is directly stated and highlight where information is absent.

Acceptance Criteria and Device Performance

The acceptance criteria for the SURGIVISIO Device are implicitly defined by its comparison to the predicate devices, specifically regarding "System accuracy" and "Device accuracy." The device claims to meet these criteria.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The document states that no clinical tests were conducted to demonstrate substantial equivalence. The performance was assessed through nonclinical tests.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated. The nonclinical tests included "Design verification tests," "Software development and testing," "Biocompatibility evaluation," "Electrical safety and electromagnetic compatibility (EMC) testing," and "validated with intended users in cadaver labs and simulated use testing." The sample sizes for these various nonclinical tests are not provided.
   • Data Provenance: The document implies these were internal nonclinical tests conducted by the manufacturer (eCential Robotics, France). There is no mention of country of origin for specific data or whether it was retrospective or prospective, as these are typically clinical study terms.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Number of Experts: Not explicitly stated. While "validated with intended users in cadaver labs and simulated use testing" suggests experts (surgeons, medical professionals) were involved, the number of such individuals is not provided.
   • Qualifications of Experts: Not explicitly stated. The term "intended users" implies relevant medical professionals, but specific qualifications (e.g., years of experience, specialty) are not detailed.

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated. Given that performance was assessed via non-clinical tests and simulated use, formal expert adjudication methods like 2+1 or 3+1 typically used in clinical imaging studies would not apply in the same way. The validation would likely involve confirmation by engineering/QA teams based on pre-defined test protocols and possibly feedback from the "intended users" during cadaver/simulated labs.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

   • MRMC Study: No. The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, no MRMC study was performed.
   • Effect Size: Not applicable, as no MRMC study was conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not explicitly separated as a "standalone" study in the context of AI algorithms. The device itself is an intraoperative guidance system intended for human-in-the-loop use. The "Design verification tests," "Software development and testing," "Biocompatibility," "Electrical safety and EMC" are all tests of the device's components and system performance in a non-human environment or against engineering standards. The accuracy metrics mentioned (e.g., "Device accuracy: <2 mm") can be considered a form of standalone performance measurement of the system's precision, separate from the clinical outcome.

6. The type of ground truth used:

   • Ground Truth: For the nonclinical performance evaluations (accuracy, safety, etc.), the ground truth would be based on engineering measurements, reference standards, and predetermined design specifications. For example, device accuracy (positional and angular) would be measured against highly precise metrology systems. In the "cadaver labs and simulated use testing," the "ground truth" would likely be the desired surgical outcome or precise instrument placement as verified by imaging or other means, in a controlled environment.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable or not provided. The SURGIVISIO Device is described as using "established computer-assisted orthopedic surgery technologies" and "optical localization technology," implying a more deterministic or rule-based system or one pre-trained on generic data, rather than a machine learning model that requires a specific training set to be described in this context. If there are AI components that rely on a training set, the size and nature of that set are not mentioned in this summary.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable or not provided, for the same reasons as point 7.

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